Implementation of a configurable laboratory information management system for use in cellular process development and...

Area of Science:

• Biotechnology
• Cell Therapy Manufacturing
• Regulatory Science

Background:

• Cell product manufacturing for clinical trials demands rigorous record-keeping from development through patient follow-up.
• Effective management of documentation for patients, materials, processes, assays, and facilities is crucial.

Purpose of the Study:

• To evaluate and implement a Laboratory Information Management System (LIMS) tailored for cell production activities.
• To assess the system's suitability for managing pre-clinical and clinical cell manufacturing, including donor management and product release.

Main Methods:

• Evaluated multiple LIMS for cost, flexibility, regulatory compliance, and integration capabilities.
• Developed and piloted a user-configurable LIMS for managing donor protocols and cell product manufacturing operations.

Main Results:

• Successfully managed blood donor eligibility, recruitment, appointments, billing, and serology.
• Utilized quality management features to track and investigate deviations during master cell bank and patient-specific product manufacturing.

Conclusions:

• The implemented LIMS supports compliance for process development and Phase I/II clinical trials.
• The system is adaptable for use in similar laboratory settings involved in cell therapy production.